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Contents 16 Human Challenge Studies: An Effective Tool for Drug Development Human challenge studies (HCS) were introduced as an alternative to community clinical trials for anti-infective agents and vaccines, previously performed in regional clinics and hospitals. In an HCS, subjects may either be inoculated with a candidate vaccine before being exposed to a live challenge virus, or dosed with an investigative therapeutic agent following experimental infection. In this article, Adrian Wildfire, SGS Infectious Diseases project director, outlines the advantages of human challenge studies. REGULATORY 18 Policy 0070 Under the Microscope: The Trade-off Between Clinical Trial Transparency and the Risk of Revealing Patient Identities The last few months have seen a battle build between the pharma industry and the EMA, following the issue of new guidance promoting greater transparency in clinical trial reporting. Specifically, ‘anonymised’ clinical study reports should now be made centrally available at the time of marketing authorisation submissions, but risk-averse manufacturers are digging in their heels. Cathal Gallagher, Life Sciences consultant for d-Wise, reviews recent developments and considers how the situation will play out. 22 Five Reasons to Embrace the ICH E6 (R2) Addendum Now: Improve Study Efficiencies by Centralising Risk-based Quality Oversight and Trial Management In November 2016, the ICH E6 (R2) Addendum to Good Clinical Practice was implemented, delivering a breath of fresh air for clinical trial sponsors and CROs who have been looking for guidance on best practices for achieving true, riskbased quality management during clinical development. Brion Regan, Product Manager, ERT, introduces this Addendum and presents the reasons why sponsors and CROs should adopt a centralised approach to risk-based trial monitoring, oversight and quality management now — to not only stay ahead of guidelines and regulations, but also to reap significant benefits across many aspects of clinical development. 26 Bridging the Clinical Data Structure Gap to Empower Holistic Risk Management Per the suggestion of regulatory agencies, there is an increased focus on the merits of adapting a risk-based monitoring (RBM) approach. Effective RBM reduces costs, improves data quality and enhances oversight, but most of the existing RBM solutions in the marketplace have significant shortcomings, in part because they make it difficult to get a holistic view of data. In this article, Sudeep Pattnaik, President & CEO of ThoughtSphere, examines the benefits of RBM, the shortcomings of existing RBM solutions, and how a new approach to data integration and analysis that leverages the latest in technology developments can improve RBM to drive more benefits and move RBM from monitoring to management. 30 Compliance Data in Clinical Research There is a great deal of emphasis on streamlining the 2 Journal for Clinical Studies

Volume 9 Issue 1

JCS - Volume 9 Issue 1  
JCS - Volume 9 Issue 1  
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